Increased Regulation for TVM Devices

The FDA is increasing regulation for medical devices known as transvaginal
mesh (TVM). These mesh devices are used for a number of reasons including,
pelvic organ prolapse and stress urinary incontinence. Going forward TVM
will be classified as high-risk when used to treat pelvic organ prolapse (POP).

Pelvic organ prolapse is a condition where the pelvic muscles and tissue
become weakened and/or stretched. The muscles may reach a point where
they can no longer support certain organs as the bladder, bowel or uterus,
which may drop and protrude into the vagina. This condition often causes
low back pain, pelvic pressure, "painful intercourse, constipation
or urinary problems such as leakage or a chronic urge to urinate."
Women may opt to have surgery performed if they suffer from significant
symptoms. TVM, when implanted is designed to reinforce the weakened pelvic
muscles, and help keep organs from dropping.

TVM devices to treat POP were reclassified from class II, which usually
includes moderate-risk devices, to class III, which normally includes
high-risk devices. The FDA is also requiring manufacturers to apply for
premarket approval (PMA) to support the safety and effectiveness of surgical
mesh for the transvaginal repair of pelvic organ prolapse. As part of
the FDA order, manufacturers of TVM devices to treat POP will have 30
months, to submit a PMA for devices that are on the market. Going forward,
manufacturers of new TVM devices must submit for PMA before those devices
can be approved for marketing.

Many of TVM devices currently on the market were approved through an accelerated
review known as the 510(k) process. In a 510(k), manufacturers can gain
approval for a medical device by showing that a product is substantially
similar to one already on the market. That procedure for approval will
no longer be available for TVM devices designed to treat POP. The new
PMA requirements will necessitate manufacturers to address safety concerns,
which led to many women with the inserted devices to file lawsuits. To
address the significant risks of TVM surgery the FDA will monitor how
women are managing years after surgery through continued post-market surveillance.

In 2002, the first mesh device to treat POP was cleared for use as a class
II moderate-risk device, and there are several manufacturers who are currently
marketing this product, including: Johnson & Johnson, Boston Scientific,
Bard, Coloplast and AMS. Over the past few years, the FDA has received
thousands of reports of adverse events from TVM insertion surgery. The
most common adverse events include "severe pelvic pain, pain during
intercourse, infection, bleeding, organ perforation and urinary problems
from mesh eroding into surrounding tissues."

We have already filed suit the major TVM manufacturers and have begun to
resolve many of our cases. If you were treated with a Transvaginal Mesh
implant call the lawyers at Rheingold, Giuffra, Ruffo & Plotkin LLP,
at (888) 260-0473. You can also contact us online
here. Protect your rights today by speaking with a knowledgeable medical device
product liability attorney today.

The information on this website is for general information purposes only.
Nothing on this site should be taken as legal advice for any individual
case or situation. This information is not intended to create, and receipt
or viewing does not constitute, an attorney-client relationship.

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